REDWOOD CITY, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, today announced that it has begun treating patients in RASolve 308, a global Phase 3 clinical trial evaluating zoldonrasib, an investigational, RAS(ON) G12D-selective inhibitor, in combination with standard of care pembrolizumab plus chemotherapy as a first-line treatment in adult patients with metastatic RAS G12D non-squamous non-small cell lung cancer (NSCLC).
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed encouraging preliminary antitumor activity and a favorable safety profile, providing strong clinical rationale for the Phase 3 RASolve 308 trial. This study, along with additional registrational trials underway in multiple tumor types across our pipeline of differentiated RAS(ON) inhibitors, underscores our commitment to establishing RAS(ON) inhibition as a new standard of care and backbone for treating patients with RAS-addicted cancers,” said Alan Sandler, M.D., chief development officer of Revolution Medicines.
RASolve 308 (NCT07777822) is a global, randomized, double-blind Phase 3 trial evaluating zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet compared with placebo in combination with pembrolizumab and platinum-based chemotherapy doublet in the treatment of adult patients with previously untreated metastatic RAS G12D non-squamous NSCLC. The primary endpoint is progression-free survival. Key secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability, and patient-reported outcomes.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%–85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. RAS mutations are among the most common oncogenic drivers in NSCLC, occurring in approximately 30% of cases. Of those, RAS G12D mutations occur in about 4% of NSCLC cases.³
About Zoldonrasib
Zoldonrasib is an investigational, oral, RAS(ON) G12D-selective covalent, tri-complex inhibitor that binds to cyclophilin A, creating a binary complex that binds to and inhibits the active, oncogenic RAS(ON) G12D mutation. RAS G12D is the most prevalent RAS mutation, accounting for approximately 29% of all RAS-driven cancers.4 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated annually in the U.S., with no targeted therapy currently approved for these patients.4 Zoldonrasib is currently being investigated as a monotherapy and in combination with other therapies, including with Revolution Medicines' RAS(ON) multi-selective inhibitor RASONQUETM (daraxonrasib), as well as standard of care regimens in lung and gastrointestinal cancers.
About Revolution Medicines, Inc.
Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the broad potential of RAS(ON) inhibition, including in lung and gastrointestinal cancers; treatment practices for lung cancer; the company’s development strategy; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company's candidates being studied.
Forward-looking statements are typically, but not always, identified by the use of words such as "aims," "anticipate," "believe," "estimate," "expect," "plan," "potential," "project," "up to," "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company's development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company's business of global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 5, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
Revolution Medicines Media & Investor Contacts
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References
¹ American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026.
2 American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed August 2026.
³ Reita D, Pabst L, Pencreach E, et al. Direct targeting KRAS mutation in non-small cell lung cancer: Focus on resistance. Cancers (Basel). 2022;14(15):1321. doi:10.3390/cancers14051321
4 Estimated using tumor mutation frequencies from Foundation Medicine Insights March 2022 and scaled to estimated patient numbers using cancer incidence from ACS Cancer Facts and Figures 2023.
